Hip Strengthening and Manual Therapy for Heel Pain Patients
Primary Purpose
Plantar Fasciitis
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Manual Therapy
Manual Therapy and Hip Strengthening
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring Manual Therapy, Pain, Hip, Muscle Strength
Eligibility Criteria
Inclusion Criteria:
- Patients with heel pain, that increases on the first steps after a period without activity and with long periods on standing position, regardless of age and gender and that didn't went under any physiotherapeutic treatment in the last 3 months.
Exclusion Criteria:
- Patients who have a history of surgery on the lower limb on the past 6 months; patients with bilateral heel pain; patients under psychiatric treatment; patients that went under a manual therapy scheme treatment for heel pain before; rheumatic syndromes; patients who receive some benefit labor or patients underage.
Sites / Locations
- Hospital Universitário Gaffréé Guinle
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual Therapy
Manual Therapy and Hip Strengthening
Arm Description
The treatment for this group will be manual therapy.
It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip.
Outcomes
Primary Outcome Measures
Level of intensity of pain
Level of intensity of pain assessed through the numerical pain scale.
Secondary Outcome Measures
Functional Status
Level of disability of the lower limb assessed through Lower Extremity Functional Scale.
Pressure pain threshold
Pressure pain threshold assessed through the algometer.
Full Information
NCT ID
NCT02624635
First Posted
December 1, 2015
Last Updated
March 12, 2018
Sponsor
Centro Universitário Augusto Motta
1. Study Identification
Unique Protocol Identification Number
NCT02624635
Brief Title
Hip Strengthening and Manual Therapy for Heel Pain Patients
Official Title
Effects of Adding Hip Strengthening to Manual Therapy for Heel Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Because of the lack of personnel and the recruitment failure of participants.
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Universitário Augusto Motta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of manual therapy and of manual therapy associated with hip strengthening in the recovery of patients with heel pain.
Heel pain decreases function, balance, walking and can cause change in the movement pattern. This alterations can induce a deficit in motor control of other structures as knee and hip. There is an importance to compare the effects of manual therapy and manual therapy associated with hip strengthening on the recover of patients with heel pain.
Detailed Description
After the initial assessment and data collection, participants will be randomly assigned to one of two intervention groups. Randomization will be held electronically in http://graphpad.com/quickcalcs/index.cfm site by simple random sampling. Patients will be treated for a maximum of 10 sessions, each session lasting about 40 minutes and each week two sessions. The maximum duration of treatment is 3 months. A physical therapist will be responsible for the screening of eligible patients and the random allocation of participants A second professional will be responsible for physical therapy initial and final evaluation and will be blind to the interventions. A third physical therapist will perform the interventions. The physiotherapist in charge of intervention will be blind to the initial and final evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Manual Therapy, Pain, Hip, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
The treatment for this group will be manual therapy.
Arm Title
Manual Therapy and Hip Strengthening
Arm Type
Experimental
Arm Description
It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
The scheme established for that intervention is as follows: joint manipulation passive ankle and foot, myofascial release technique (gastrocnemius, soleus muscle and plantar fascia), neural mobilization (nerve tibial) and stretching the plantar region and sural triceps, following the recommendations described by Mcpoil et al. (2008).
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Hip Strengthening
Intervention Description
It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip (iliac muscle, psoas, gluteus maximus, gluteus medius and gluteus minimus) and the treatment schedule established for this intervention is the use of exercises with progressive resistance. Will be performed 3 sets of 10 reps with 30 seconds rest between each set, according to the guidelines of the American College of Sports Medicine (ACSM, 2014). The home exercises consist of repeating the same procedures performed for supervised strengthening. The calculation of the ideal individual load will be carried by Brzycki formula, i.e. one repetition maximum (1RM) = weight ÷ [1.0278 - (0.0278 x number of repetitions)] as was used by (Shirazi et al., 2007).
Primary Outcome Measure Information:
Title
Level of intensity of pain
Description
Level of intensity of pain assessed through the numerical pain scale.
Time Frame
Up to three months
Secondary Outcome Measure Information:
Title
Functional Status
Description
Level of disability of the lower limb assessed through Lower Extremity Functional Scale.
Time Frame
Up to three months
Title
Pressure pain threshold
Description
Pressure pain threshold assessed through the algometer.
Time Frame
Up to three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with heel pain, that increases on the first steps after a period without activity and with long periods on standing position, regardless of age and gender and that didn't went under any physiotherapeutic treatment in the last 3 months.
Exclusion Criteria:
Patients who have a history of surgery on the lower limb on the past 6 months; patients with bilateral heel pain; patients under psychiatric treatment; patients that went under a manual therapy scheme treatment for heel pain before; rheumatic syndromes; patients who receive some benefit labor or patients underage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leandro AC Nogueira, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Gaffréé Guinle
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
9498581
Citation
Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.
Results Reference
background
PubMed Identifier
24703512
Citation
Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.
Results Reference
background
PubMed Identifier
20627575
Citation
Moore AR, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, McQuay H; ACTINPAIN writing group of the IASP Special Interest Group (SIG) on Systematic Reviews in Pain Relief and the Cochrane Pain, Palliative and Supportive Care Systematic Review Group editors. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain. 2010 Sep;150(3):386-389. doi: 10.1016/j.pain.2010.05.011. Epub 2010 Jun 2. No abstract available.
Results Reference
background
PubMed Identifier
16141740
Citation
Babcock MS, Foster L, Pasquina P, Jabbari B. Treatment of pain attributed to plantar fasciitis with botulinum toxin a: a short-term, randomized, placebo-controlled, double-blind study. Am J Phys Med Rehabil. 2005 Sep;84(9):649-54. doi: 10.1097/01.phm.0000176339.73591.d7.
Results Reference
background
PubMed Identifier
2189536
Citation
Bergmann JN. History and mechanical control of heel spur pain. Clin Podiatr Med Surg. 1990 Apr;7(2):243-59.
Results Reference
background
PubMed Identifier
10201543
Citation
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
Results Reference
background
PubMed Identifier
12219661
Citation
Buch M, Knorr U, Fleming L, Theodore G, Amendola A, Bachmann C, Zingas C, Siebert WE. [Extracorporeal shockwave therapy in symptomatic heel spurs. An overview]. Orthopade. 2002 Jul;31(7):637-44. doi: 10.1007/s00132-002-0323-z. German.
Results Reference
background
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Hip Strengthening and Manual Therapy for Heel Pain Patients
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